Last updated 29 days ago
Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study
105 patients around the world
Available in Argentina
Protocol Number: FH-79
Study Objetives:
- Evaluate the acceptability, uptake, and completion of HPV vaccination.
- Determine the baseline prevalence (before HPV vaccination) and incidence of
vaccine-specific genotypes of nonavalent HPV in the anus (anatomical site) after
vaccination.
- Determine the initial prevalence (before HPV vaccination) and incidence of anal
cytological lesions after HPV vaccination.-
- Determine the initial prevalence (before HPV vaccination) and incidence of oral and
anogenital lesions associated with HPV, according to physical examination, after HPV
vaccination.
- Analyze barriers and facilitators to the acceptability, uptake, and completion of
HPV vaccination from the perspective of MSM and TGW.
Patient Population: MSM (men who have sex with men) and TGW (transgender woman)
Study design: Phase IV. Longitudinal and prospective study for which a cohort of 100 MSM
(men who have sex with men)and TGW (transgender woman) will be formed at Fundación
Huésped. Pilot study of mixed quantitative and qualitative methodology.
Regimens: Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0,
2, 6 months). (Trade name GARDASIL 9 -MSD), Duration: 12 months
Sample size: 105 subjects
Fundación Huésped
1Research sites
105Patients around the world
This study is for people with
Hpv
Hpv infection
Requirements for the patient
To 90 Years
Male
Medical requirements
- Accept participation in the study by signing informed consent.Age ≥18 years old.People who consider themselves men who have sex with men or transgender women.All eligible people with HIV must meet the following.Stable antiretroviral treatment during the last 6 months and with undetectable viral load within the same period. Regarding ART, a change associated with toxicity or simplification may be allowed before 12 weeks of the selection visit, with undetectable VL between 12 weeks and the selection visit.CD4 cell count ≥ 200 cells/ml in the last 6 months.
- Have a history or current suspicion of cancer.Have a known history or current suspicion of high-grade lesion or anal intraepithelial neoplasia related to HPV.Have received any dose of HPV vaccine at some time in your life.Have received any vaccine in the last 30 days.Have a known allergy to any of the components of the HPV vaccine.Have a history of a previous severe allergic reaction, regardless of the cause.Presenting an acute illness that could alter the study evaluations or could put the participant at risk, according to the researcher's criteria.Present chronic or acute immunosuppression except HIV.Have received antineoplastic and immunomodulatory agents or radiotherapy in the 6 months prior to the study or plan to receive these treatments during the study period.Having chronic diseases without adequate control.Have a diagnosis of ongoing malignant disease.Having received immunoglobulins, blood or blood products in the last 3 months.Do not participate in another intervention study.That he is not an employee or first-degree relative of any member of the institution.Any condition or clinical situation that the investigator considers participation in the study may pose a risk to the patient.People with chronic HBV infection, who are receiving treatment and have normal transaminases for the last 6 months can be included in the study.People with chronic HCV infection can enter the study if they have normal transaminases for the last 6 months and do not plan to start treatment during the study.In either case, transaminases can be requested through the study if they are not available.
Sites
Fundación Huésped
StudyHPVac
SponsorFundación Huésped
Conditions
Hpv infection
Requirements
To 90 YearsMale
Unique study IDclinicaltrials.gov
NCT06588257
